Evidence map›Paper›PMID 38689273›Full record

ArticleBMC psychiatry2024

The efficacy of real versus sham external Trigeminal Nerve Stimulation (eTNS) in youth with Attention-Deficit/Hyperactivity Disorder (ADHD) over 4 weeks: a protocol for a multi-centre, double-blind, randomized, parallel-group, phase IIb study (ATTENS).

Katya Rubia, Lena Johansson, Ben Carter, Dominic Stringer, Paramala Santosh, Mitul A Mehta, Aldo Alberto Conti, Natali Bozhilova, Irem Ece Eraydin, Samuele Cortese

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.1field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Katya Rubia *Department of Child & Adolescent Psychiatry/PO46 Institute of Psychiatry, Psychology & Neurosciences King's College London, De Crespigny Park, London, SE5 8AF, UK. katya.rubia@kcl.ac.uk.
Lena Johansson *Department of Child & Adolescent Psychiatry/PO46 Institute of Psychiatry, Psychology & Neurosciences King's College London, De Crespigny Park, London, SE5 8AF, UK.
Ben CarterDepartment of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Dominic StringerDepartment of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Paramala SantoshDepartment of Child & Adolescent Psychiatry/PO46 Institute of Psychiatry, Psychology & Neurosciences King's College London, De Crespigny Park, London, SE5 8AF, UK.
Mitul A MehtaDepartment for Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Aldo Alberto ContiDepartment of Child & Adolescent Psychiatry/PO46 Institute of Psychiatry, Psychology & Neurosciences King's College London, De Crespigny Park, London, SE5 8AF, UK.
Natali BozhilovaDepartment of Child & Adolescent Psychiatry/PO46 Institute of Psychiatry, Psychology & Neurosciences King's College London, De Crespigny Park, London, SE5 8AF, UK.
Irem Ece EraydinCentre for Innovation in Mental Health, School of Psychology, University of Southampton, Southampton, UK.
Samuele CorteseCentre for Innovation in Mental Health, School of Psychology, University of Southampton, Southampton, UK.
King's College London · GBSolent NHS Trust · GBSouth London and Maudsley NHS Foundation Trust · GBUniversity of Southampton · GB

Funding

National Institute for Health and Care Research NIHR130077
6 · The paper itself

Abstract

backgroundAttention Deficit/Hyperactivity Disorder (ADHD), if severe, is usually treated with stimulant or non-stimulant medication. However, users prefer non-drug treatments due to side effects. Alternative non-medication treatments have so far only shown modest effects. External trigeminal nerve stimulation (eTNS) is a minimal risk, non-invasive neuromodulation device, targeting the trigeminal system. It was approved for ADHD in 2019 by the USA Food and Drug administration (FDA) based on a small proof of concept randomised controlled trial (RCT) in 62 children with ADHD showing improvement of ADHD symptoms after 4 weeks of nightly real versus sham eTNS with minimal side effects. We present here the protocol of a larger confirmatory phase IIb study testing efficacy, longer-term persistency of effects and underlying mechanisms of action.

methodsA confirmatory, sham-controlled, double-blind, parallel-arm, multi-centre phase IIb RCT of 4 weeks of eTNS in 150 youth with ADHD, recruited in London, Portsmouth, and Southampton, UK. Youth with ADHD will be randomized to either real or sham eTNS, applied nightly for 4 weeks. Primary outcome is the change in the investigator-administered parent rated ADHD rating scale. Secondary outcomes are other clinical and cognitive measures, objective hyperactivity and pupillometry measures, side effects, and maintenance of effects over 6 months. The mechanisms of action will be tested in a subgroup of 56 participants using magnetic resonance imaging (MRI) before and after the 4-week treatment. DISCUSSION: This multi-centre phase IIb RCT will confirm whether eTNS is effective in a larger age range of children and adolescents with ADHD, whether it improves cognition and other clinical measures, whether efficacy persists at 6 months and it will test underlying brain mechanisms. The results will establish whether eTNS is effective and safe as a novel non-pharmacological treatment for ADHD.

trial registrationISRCTN82129325 on 02/08/2021, https://doi.org/10.1186/ISRCTN82129325 .

Indexed as

Attention Deficit Disorder with HyperactivityTrigeminal NerveAdolescentChildClinical Trials, Phase II as TopicDouble-Blind MethodFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeADHDAttention-DeficitEFeTNSExecutive functionsExternal transcutaneous Trigeminal Nerve StimulationExternal trigeminal nerve stimulationfMRIFunctional magnetic resonance imagingHyperactivity DisorderSupraorbital transcutaneous stimulationTENSTNSTranscutaneous electrical nerve stimulationTranscutaneous external supraorbital nerve stimulationTranscutaneous supraorbital nerve stimulationTrigeminal nerve stimulationTrigeminal transcutaneous nerve stimulation

Identifiers

PMID38689273
PMCPMC11059677
OpenAlexW4396513927

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.